Peritoneal AdhesionsNCT02847676
Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery
An observational study of Peritoneal Adhesions, run by Pius-Hospital Oldenburg.
Trial summary
Our study aims to characterise a possible pluripotent cell population in the abdomen responsible for peritoneal adhesions. We therefore want to take samples from women undergoing planned laparoscopic surgery with and without adhesions, isolate the cells and characterise them for markers of pluripotency. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Adhesions
- What is being tested?
- Tissue sample donation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing scheduled pelvic gynecological surgical treatment, at the Gynecology Department of Pius Hospital, Oldenburg.
Who may be able to join
- Woman equal to and above 18 years of age.
- Woman with a negative pregnancy test at the time of recruitment, and sufficient contraception from time of
- Woman with any gynecological pathology requiring scheduled pelvic gynecological surgery, either laparotomy or laparoscopy.
- Woman without primary peritoneal disease.
Who cannot join
- Woman with a primary peritoneal pathology.
- Emergency surgery
- Patients under systemic immunosuppressive therapy in the previous 6 months
- Patients with current intra-abdominal or pelvic abscess or systemic infection
- Pregnant woman
- Simultaneous participation in another clinical trail
Trial locations and contacts
No sites are listed yet.
About this study
Our study aims to characterise a possible pluripotent cell population in the abdomen responsible for peritoneal adhesions. We therefore want to take samples from women undergoing planned laparoscopic surgery with and without adhesions, isolate the cells and characterise them for markers of pluripotency.
Read the detailed description
Peritoneal adhesions are connective tissue bands between two normally separate anatomical structures within the abdominal or pelvic cavity. Those adhesions can occur after gynaecological or other surgeries involving the pelvis or abdomen. Adhesions have severe clinical as well as economical Consequences. There is substantial morbidity (from chronical pain to obstructions and infertility) and a higher surgical risk if additional surgery is needed, due to a higher intraoperative blood loss and a higher incidence of lacerations when peritoneal adhesions are present. In combination with a prolonged surgery duration, the economical impact is tremendous. A 2011 study estimated the cost of adhesion - related surgeries to be 2,3 billion US dollar exclusively in the USA. 46.3% of those surgeries had their origin or localisation in the gynaecological area. The genesis of adhesiolysis - obligatory peritoneal adhesions remains unclear to this date.
After all surgeries cytokine induced fibrotic bands appear within 72 hours. Usually those bands are eliminated by a fibrinolytic sequence within 10 days.
For Adhesions that persist afterwards the generally accepted assumption is, that there is a failure of the fibrinolytic sequence with unknown origin. Adhesions which persist for more than 10-14 days become thicker and vascularised. In those "adult" adhesions not only fibrin is found but also fat tissue, smooth muscles and myelinised and un - myelinised axons.
In developmental biology those tissues differentiate from different germ layers, namely mesoderm and ectoderm. Finding cells from multiple germ layers points towards a pluri -, multi-, or stem cell like precursor cell from which those adhesions develop. Such a cellpopulation has not been characterised in the abdomen to the date of writing, though Studies have shown evidence (ranging from mesothelial - to - mesenchymal shift to Clusters of differentiation from multiple germ layers) which made multiple researchers postulate a pluripotent precursor cell located in the submesothelium.
In our research we will therefore take peritoneal samples from adhesions, peritoneal wall lining and omentum in subjects with and without peritoneal adhesions in subjects undergoing indicated laparoscopic surgery at the gynaecological ward at the Pius hospital in Oldenburg.
The samples are routinely taken as part of the procedure and usually discarded. At least 24 hours prior to surgery, the subjects will have a chance to give their informed consent to donate those samples for our study. The study is thus designed in a way that subjects won't undergo additional risk by participating in the study. Taking part or the refusal hereof won't have any effect on the treatment or surgical outcome for the subjects. Also, taking part in our study won't have any benefits or additional risks for the subjects.
The samples will then be taken to the university of Leipzig, where we will culture, isolate and characterise the cells. Characterisation will mostly be the application of pluripotency markers, cell sorting and immunoassays. Expression profiles will be used to further understand the mesothelial - to - mesenchymal shift. Depending on our findings the protocol for analysis will be adjusted in consultation with Prof. dr. dr. De Wilde and Prof. dr. Bader.
The study will approximately take 6 months, with an additional 6 months for writing and publication. The study is funded by the research funding pool of the university of Oldenburg.
- Conditions
- Peritoneal Adhesions
- Being tested
- Tissue sample donation
- Keywords
- Peritoneal adhesions, Stem cells, MSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue sample donationProcedure or surgery
Patients undergo planned gynaecological surgery. Tissue samples, which are routinely taken, are donated.
| Study group | Role | What they receive |
|---|---|---|
| No previous surgery, adhesions present. | Patients have had no previous abdominal surgery. Inspection shows peritoneal adhesions. Receives: Procedure: Tissue sample donation | |
| No previous surgery, no adhesions present. | Patients have had no previous abdominal surgery. Inspection shows no peritoneal adhesions. Receives: Procedure: Tissue sample donation | |
| Previous surgery, adhesions present. | Patients have had previous abdominal surgery. Inspection shows peritoneal adhesions. Receives: Procedure: Tissue sample donation | |
| Previous surgery, no adhesions present. | Patients have had previous abdominal surgery. Inspection shows no peritoneal adhesions. Receives: Procedure: Tissue sample donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4)
days since previous surgery
Measured: at least 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal AdhesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pius-Hospital Oldenburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, University of Oldenburg
- Responsible party
- Principal investigator, Prof. Dr. Dr. med. Rudy Leon De Wilde, Pius-Hospital Oldenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847676
- Sponsor's protocol ID
- PHDW-005
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT02847676
- Acronym / sponsor ID
- PHDW-005
- Conditions
- Peritoneal Adhesions
- Keywords
- Peritoneal adhesions, Stem cells, MSC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pius-Hospital OldenburgUniversity, hospital or other
- Collaborators
- University of Leipzig, University of Oldenburg
- Study start
- Aug 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aims to characterise a possible pluripotent cell population in the abdomen responsible for peritoneal adhesions. We therefore want to take samples from women undergoing planned laparoscopic surgery with and without adhesions, isolate the cells and characterise them for markers of pluripotency.
Detailed description
Peritoneal adhesions are connective tissue bands between two normally separate anatomical structures within the abdominal or pelvic cavity. Those adhesions can occur after gynaecological or other surgeries involving the pelvis or abdomen. Adhesions have severe clinical as well as economical Consequences. There is substantial morbidity (from chronical pain to obstructions and infertility) and a higher surgical risk if additional surgery is needed, due to a higher intraoperative blood loss and a higher incidence of lacerations when peritoneal adhesions are present. In combination with a prolonged surgery duration, the economical impact is tremendous. A 2011 study estimated the cost of adhesion - related surgeries to be 2,3 billion US dollar exclusively in the USA. 46.3% of those surgeries had their origin or localisation in the gynaecological area. The genesis of adhesiolysis - obligatory peritoneal adhesions remains unclear to this date.
After all surgeries cytokine induced fibrotic bands appear within 72 hours. Usually those bands are eliminated by a fibrinolytic sequence within 10 days.
For Adhesions that persist afterwards the generally accepted assumption is, that there is a failure of the fibrinolytic sequence with unknown origin. Adhesions which persist for more than 10-14 days become thicker and vascularised. In those "adult" adhesions not only fibrin is found but also fat tissue, smooth muscles and myelinised and un - myelinised axons.
In developmental biology those tissues differentiate from different germ layers, namely mesoderm and ectoderm. Finding cells from multiple germ layers points towards a pluri -, multi-, or stem cell like precursor cell from which those adhesions develop. Such a cellpopulation has not been characterised in the abdomen to the date of writing, though Studies have shown evidence (ranging from mesothelial - to - mesenchymal shift to Clusters of differentiation from multiple germ layers) which made multiple researchers postulate a pluripotent precursor cell located in the submesothelium.
In our research we will therefore take peritoneal samples from adhesions, peritoneal wall lining and omentum in subjects with and without peritoneal adhesions in subjects undergoing indicated laparoscopic surgery at the gynaecological ward at the Pius hospital in Oldenburg.
The samples are routinely taken as part of the procedure and usually discarded. At least 24 hours prior to surgery, the subjects will have a chance to give their informed consent to donate those samples for our study. The study is thus designed in a way that subjects won't undergo additional risk by participating in the study. Taking part or the refusal hereof won't have any effect on the treatment or surgical outcome for the subjects. Also, taking part in our study won't have any benefits or additional risks for the subjects.
The samples will then be taken to the university of Leipzig, where we will culture, isolate and characterise the cells. Characterisation will mostly be the application of pluripotency markers, cell sorting and immunoassays. Expression profiles will be used to further understand the mesothelial - to - mesenchymal shift. Depending on our findings the protocol for analysis will be adjusted in consultation with Prof. dr. dr. De Wilde and Prof. dr. Bader.
The study will approximately take 6 months, with an additional 6 months for writing and publication. The study is funded by the research funding pool of the university of Oldenburg.
Study design
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No previous surgery, adhesions present. | – | Procedure: Tissue sample donationPatients have had no previous abdominal surgery. Inspection shows peritoneal adhesions. |
| No previous surgery, no adhesions present. | – | Procedure: Tissue sample donationPatients have had no previous abdominal surgery. Inspection shows no peritoneal adhesions. |
| Previous surgery, adhesions present. | – | Procedure: Tissue sample donationPatients have had previous abdominal surgery. Inspection shows peritoneal adhesions. |
| Previous surgery, no adhesions present. | – | Procedure: Tissue sample donationPatients have had previous abdominal surgery. Inspection shows no peritoneal adhesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing scheduled pelvic gynecological surgical treatment, at the Gynecology Department of Pius Hospital, Oldenburg.
Key inclusion criteria (4 listed)
- Woman equal to and above 18 years of age.
- Woman with a negative pregnancy test at the time of recruitment, and sufficient contraception from time of
- Woman with any gynecological pathology requiring scheduled pelvic gynecological surgery, either laparotomy or laparoscopy.
- Woman without primary peritoneal disease.
Key exclusion criteria (6 listed)
- Woman with a primary peritoneal pathology.
- Emergency surgery
- Patients under systemic immunosuppressive therapy in the previous 6 months
- Patients with current intra-abdominal or pelvic abscess or systemic infection
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue sample donationPatients undergo planned gynaecological surgery. Tissue samples, which are routinely taken, are donated. | Procedure or surgery | No previous surgery, adhesions present., No previous surgery, no adhesions present., Previous surgery, adhesions present., Previous surgery, no adhesions present. |
Primary outcome
Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4)
Time frame: at least 10
days since previous surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Adhesions, run by Pius-Hospital Oldenburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rudy Leon De Wilde, Prof. dr. dr. med (0441 2291501, gyn-sekretariat@pius-hospital.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4) (time frame: at least 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.